(elranatamab-bcmm)

Prescribing Information
Download Prescribing Information

2 DOSAGE AND ADMINISTRATION

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosing Information

Administer ELREXFIO subcutaneously according to the step-up dosing schedule to reduce the incidence and severity of cytokine release syndrome (CRS).

Administer pre-treatment medications prior to each dose in the ELREXFIO step-up dosing schedule, which includes step-up dose 1, step-up dose 2, and the first treatment dose as recommended [see Dosage and Administration (2.2, 2.3)].

ELREXFIO should only be administered by a qualified healthcare professional with appropriate medical support to manage severe reactions such as CRS and neurologic toxicity, including ICANS [see Warnings and Precautions (5.1, 5.2)].

Due to the risk of CRS, patients should be hospitalized for 48 hours after administration of the first step-up dose, and for 24 hours after administration of the second step-up dose.

2.2 Recommended Dosage

For subcutaneous injection only.

The recommended dosing schedule for ELREXFIO is provided in Table 1. The recommended dosages of ELREXFIO subcutaneous injection are: step-up dose 1 of 12 mg on Day 1, step-up dose 2 of 32 mg on Day 4, followed by the first treatment dose of 76 mg on Day 8, and then 76 mg weekly thereafter through week 24.

For patients who have received at least 24 weeks of treatment with ELREXFIO and have achieved a response [partial response (PR) or better] and maintained this response for at least 2 months, the dose interval should transition to an every two-week schedule. For patients who have received at least 24 weeks of treatment with ELREXFIO at the every two-week dosing schedule and have maintained the response, the dose interval should transition to an every four-week schedule.

Continue treatment with ELREXFIO until disease progression or unacceptable toxicity.

Administer pre-treatment medications prior to each dose in the ELREXFIO step-up dosing schedule, which includes step-up dose 1, step-up dose 2, and the first treatment dose as recommended [see Dosage and Administration (2.3)].

Table 1. ELREXFIO Dosing Schedule
Note: See Table 2 for recommendations on restarting ELREXFIO after dose delays.
*
Administer pre-treatment medications prior to each dose in the ELREXFIO step-up dosing schedule, which includes step-up dose 1, step-up dose 2, and the first treatment dose [see Dosage and Administration (2.3)].
†
A minimum of 2 days should be maintained between step-up dose 1 (12 mg) and step-up dose 2 (32 mg).
‡
A minimum of 3 days should be maintained between step-up dose 2 (32 mg) and the first treatment (76 mg) dose.
§
A minimum of 6 days should be maintained between treatment doses.

Dosing Schedule

Day

ELREXFIO Dose

Step-up Dosing Schedule

Day 1*

Step-up dose 1

12 mg

Day 4*†

Step-up dose 2

32 mg

Day 8*‡

First treatment dose

76 mg

Weekly Dosing Schedule

One week after first treatment dose and weekly thereafter§ through week 24

Subsequent treatment doses

76 mg

Biweekly (Every 2 Week) Dosing Schedule

*Responders only week 25 onward

Week 25 and every 2 weeks thereafter§

through week 48

Subsequent treatment doses

76 mg

Every 4 Week Dosing Schedule

*In patients who have maintained the response following 24 weeks of treatment at the biweekly dosing schedule

Week 49 and every 4 weeks thereafter§

Subsequent treatment doses

76 mg

2.3 Recommended Pre-treatment Medications

Administer the following pre-treatment medications approximately 1 hour before the first three doses of ELREXFIO in the step-up dosing schedule, which includes step-up dose 1, step-up dose 2, and the first treatment dose as described in Table 1 to reduce the risk of CRS [see Warnings and Precautions (5.1)]:

•
acetaminophen (or equivalent) 650 mg orally
•
dexamethasone (or equivalent) 20 mg orally or intravenously
•
diphenhydramine (or equivalent) 25 mg orally

2.4 Restarting ELREXFIO After Dosage Delay

If a dose of ELREXFIO is delayed, restart therapy based on the recommendations listed in Table 2 and resume the dosing schedule accordingly [see Dosage and Administration (2.2)]. Administer pre-treatment medications as indicated in Table 2.

Table 2. Recommendation for Restarting Therapy with ELREXFIO After Dosage Delay
*
Administer pre-treatment medications prior to the ELREXFIO dose [see Dosage and Administration (2.3)].
†
Consider benefit-risk of restarting ELREXFIO in patients who require a dose delay of more than 56 days due to an adverse reaction.

Last Dose Administered

Time Since the Last Dose Administered

Action for Next Dose

Step-up dose 1 (12 mg)

2 weeks or less (≤14 days)

Restart ELREXFIO at step-up dose 2 (32 mg).* If tolerated, increase to 76 mg 4 days later.

Greater than 2 weeks (>14 days)

Restart ELREXFIO step-up dosing schedule at step-up dose 1 (12 mg).*

Step-up dose 2 (32 mg)

2 weeks or less (≤14 days)

Restart ELREXFIO at 76 mg.*

Greater than 2 weeks to less than or equal to 4 weeks (15 days to ≤28 days)

Restart ELREXFIO at step-up dose 2 (32 mg).* If tolerated, increase to 76 mg 1 week later.

Greater than 4 weeks (>28 days)

Restart ELREXFIO step-up dosing schedule at step-up dose 1 (12 mg).*

Any weekly treatment dose (76 mg)

8 weeks or less (≤56 days)

Restart ELREXFIO at 76 mg.

Greater than 8 weeks to less or equal to 12 weeks (57 days to ≤84 days)†

Restart ELREXFIO at step-up dose 2 (32 mg).*If tolerated, increase to 76 mg 1 week later.

Greater than 12 weeks (>84 days)†

Restart ELREXFIO step-up dosing schedule at step-up dose 1 (12 mg).*

Any biweekly or every-4-week treatment dose (76 mg)

12 weeks or less (≤84 days)

Restart ELREXFIO at 76 mg.

Greater than 12 weeks (>84 days)†

Restart ELREXFIO step-up dosing schedule at step-up dose 1 (12 mg).*

2.5 Dosage Modifications for Adverse Reactions

Dosage reductions of ELREXFIO are not recommended.

Dosage delays may be required to manage toxicities related to ELREXFIO [see Warnings and Precautions (5)]. Recommendations on restarting ELREXFIO after a dose delay are provided in Table 2.

See Table 3 and Table 4 for recommended actions for adverse reactions of CRS and ICANS, respectively. See Table 5 for recommended actions for neurologic toxicity excluding ICANS and Table 6 for recommended actions for other adverse reactions following administration of ELREXFIO. Consider further management per current practice guidelines.

Management of CRS, Neurologic Toxicity Including ICANS

Cytokine Release Syndrome (CRS)

Management recommendations for CRS are summarized in Table 3.

Identify CRS based on clinical presentation [see Warnings and Precautions (5.1)]. Evaluate and treat other causes of fever, hypoxia, and hypotension.

If CRS is suspected, withhold ELREXFIO until CRS resolves. Manage CRS according to the recommendations in Table 3 and consider further management per current practice guidelines. Administer supportive therapy for CRS, which may include intensive care for severe or life-threatening CRS. Consider laboratory testing to monitor for disseminated intravascular coagulation (DIC), hematology parameters, as well as pulmonary, cardiac, renal, and hepatic function.

Table 3. Recommendations for Management of CRS
*
Based on American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading criteria for CRS.
†
Attributed to CRS. Fever may not always be present concurrently with hypotension or hypoxia as it may be masked by interventions such as antipyretics or anti-cytokine therapy.
‡
See Table 2 for recommendations on restarting ELREXFIO after dose delays.
§
Low-flow nasal cannula is ≤6 L/min, and high-flow nasal cannula is >6 L/min.

Grade*

Presenting Symptoms

Actions

Grade 1

Temperature ≥100.4 °F (38 °C)†

•
Withhold ELREXFIO until CRS resolves.‡
•
Administer pretreatment medications prior to next dose of ELREXFIO.

Grade 2

Temperature ≥100.4 °F (38 °C) with either:

•
Hypotension responsive to fluid and not requiring vasopressors, and/or
•
Oxygen requirement of low-flow nasal cannula§ or blow-by
•
Withhold ELREXFIO until CRS resolves.‡
•
Monitor patients daily for 48 hours following the next dose of ELREXFIO. Instruct patients to remain within proximity of a healthcare facility, and consider hospitalization.
•
Administer pretreatment medications prior to next dose of ELREXFIO.

Grade 3

(First occurrence)

Temperature ≥100.4 °F (38 °C) with either:

•
Hypotension requiring one vasopressor with or without vasopressin, and/or
•
Oxygen requirement of high-flow nasal cannula§, facemask, non-rebreather mask, or Venturi mask
•
Withhold ELREXFIO until CRS resolves.‡
•
Provide supportive therapy, which may include intensive care.
•
Patients should be hospitalized for 48 hours following the next dose of ELREXFIO.
•
Administer pretreatment medications prior to next dose of ELREXFIO.

Grade 3 (Recurrent)

Temperature ≥100.4 °F (38 °C) with either:

•
Hypotension requiring one vasopressor with or without vasopressin, and/or
•
Oxygen requirement of high-flow nasal cannula§, facemask, non-rebreather mask, or Venturi mask
•
Permanently discontinue therapy with ELREXFIO.
•
Provide supportive therapy, which may include intensive care.

Grade 4

Temperature ≥100.4 °F (38 °C) with either:

•
Hypotension requiring multiple vasopressors (excluding vasopressin), and/or
•
Oxygen requirement of positive pressure (e.g., continuous positive airway pressure [CPAP], bilevel positive airway pressure [BiPAP], intubation, and mechanical ventilation)
•
Permanently discontinue therapy with ELREXFIO.
•
Provide supportive therapy, which may include intensive care.

Neurologic Toxicity Including ICANS

Management recommendations for ICANS and neurologic toxicity are summarized in Table 4 and Table 5.

At the first sign of neurologic toxicity, including ICANS, withhold ELREXFIO and consider neurology evaluation. Rule out other causes of neurologic symptoms. Provide supportive therapy, which may include intensive care, for severe or life-threatening neurologic toxicities, including ICANS [see Warnings and Precautions (5.2)]. Manage ICANS according to the recommendations in Table 4 and consider further management per current practice guidelines.

Table 4. Recommendations for Management of ICANS
*
Based on American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading criteria for ICANS.
†
Management is determined by the most severe event, not attributable to any other cause.
‡
If patient is arousable and able to perform Immune Effector Cell-Associated Encephalopathy (ICE) Assessment, assess: Orientation (oriented to year, month, city, hospital = 4 points); Naming (name 3 objects, e.g., point to clock, pen, button = 3 points); Following Commands (e.g., “show me 2 fingers” or “close your eyes and stick out your tongue” = 1 point); Writing (ability to write a standard sentence = 1 point); and Attention (count backwards from 100 by ten = 1 point). If patient is unarousable and unable to perform ICE Assessment (Grade 4 ICANS) = 0 points.
§
Not attributable to any other cause.
See Table 2 for recommendations on restarting ELREXFIO after dose delays.
#
All references to dexamethasone administration are dexamethasone or equivalent medications.

Grade*

Presenting Symptoms†

Actions

Grade 1

ICE score 7-9‡

Or depressed level of consciousness§: awakens spontaneously.

•
Withhold ELREXFIO until ICANS resolves.
•
Monitor neurologic symptoms and consider consultation with a neurologist and other specialists for further evaluation and management.
•
Consider non-sedating, anti-seizure medications (e.g., levetiracetam) for seizure prophylaxis.

Grade 2

ICE score 3-6‡

Or depressed level of consciousness§: awakens to voice.

•
Withhold ELREXFIO until ICANS resolves.
•
Administer dexamethasone# 10 mg intravenously every 6 hours. Continue dexamethasone use until resolution to Grade 1 or less, then taper.
•
Monitor neurologic symptoms and consider consultation with a neurologist and other specialists for further evaluation and management.
•
Consider non-sedating, anti-seizure medications (e.g., levetiracetam) for seizure prophylaxis.
•
Monitor patients daily for 48 hours following the next dose of ELREXFIO. Instruct patients to remain within proximity of a healthcare facility, and consider hospitalization.

Grade 3

(First occurrence)

ICE score 0-2‡

or depressed level of consciousness§: awakens only to tactile stimulus,

or seizures§, either:

•
any clinical seizure, focal or generalized, that resolves rapidly, or
•
non-convulsive seizures on electroencephalogram (EEG) that resolve with intervention,

or raised intracranial pressure: focal/local edema on neuroimaging§

•
Withhold ELREXFIO until ICANS resolves.
•
Administer dexamethasone# 10 mg intravenously every 6 hours. Continue dexamethasone use until resolution to Grade 1 or less, then taper.
•
Monitor neurologic symptoms and consider consultation with a neurologist and other specialists for further evaluation and management.
•
Consider non-sedating, anti-seizure medications (e.g., levetiracetam) for seizure prophylaxis.
•
Provide supportive therapy, which may include intensive care.
•
Patients should be hospitalized for 48 hours following the next dose of ELREXFIO.

Grade 3 (recurrent)

ICE score 0-2‡

or depressed level of consciousness§: awakens only to tactile stimulus,

or seizures§, either:

•
any clinical seizure, focal or generalized, that resolves rapidly, or
•
non-convulsive seizures on electroencephalogram (EEG) that resolve with intervention,

or raised intracranial pressure: focal/local edema on neuroimaging§

•
Permanently discontinue ELREXFIO.
•
Administer dexamethasone# 10 mg intravenously every 6 hours. Continue dexamethasone use until resolution to Grade 1 or less, then taper.
•
Monitor neurologic symptoms and consider consultation with a neurologist and other specialists for further evaluation and management.
•
Consider non-sedating, anti-seizure medications (e.g., levetiracetam) for seizure prophylaxis.
•
Provide supportive therapy, which may include intensive care.

Grade 4

ICE score 0‡

Or, depressed level of consciousness§ either:

•
patient is unarousable or requires vigorous or repetitive tactile stimuli to arouse, or
•
stupor or coma,

or seizures§, either:

•
life-threatening prolonged seizure (>5 minutes), or
•
repetitive clinical or electrical seizures without return to baseline in between,

or motor findings§:

•
deep focal motor weakness such as hemiparesis or paraparesis,

or raised intracranial pressure/cerebral edema§, with signs/symptoms such as:

•
diffuse cerebral edema on neuroimaging, or
•
decerebrate or decorticate posturing, or
•
cranial nerve VI palsy, or
•
papilledema, or
•
Cushing’s triad
•
Permanently discontinue ELREXFIO.
•
Administer dexamethasone# 10 mg intravenously every 6 hours. Continue dexamethasone use until resolution to Grade 1 or less, then taper.
•
Alternatively, consider administration of methylprednisolone 1,000 mg per day intravenously for 3 days.
•
Monitor neurologic symptoms and consider consultation with a neurologist and other specialists for further evaluation and management.
•
Consider non-sedating, anti-seizure medications (e.g., levetiracetam) for seizure prophylaxis.
•
Provide supportive therapy, which may include intensive care.
Table 5. Recommendations for Management of Neurologic Toxicity, Excluding ICANS

Adverse Reaction

Severity

Actions

Neurologic Toxicity (excluding ICANS)

Grade 1

•
Withhold ELREXFIO until neurologic toxicity symptoms resolve or stabilize.

Grade 2

Grade 3 (First occurrence)

•
Withhold ELREXFIO until neurologic toxicity symptoms improve to Grade 1 or less.
•
Provide supportive therapy.

Grade 3 (Recurrent)

Grade 4

•
Permanently discontinue ELREXFIO.
•
Provide supportive therapy, which may include intensive care.
Table 6. Recommended Dosage Modifications for Other Adverse Reactions
*
See Table 2 for recommendations on restarting ELREXFIO after dose delays.
†
Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 5.0.

Adverse Reactions

Severity

Actions

Hematologic Adverse Reactions

[see Warnings and Precautions (5.5)]

Absolute neutrophil count less than 0.5 x 109/L

•
Withhold ELREXFIO until absolute neutrophil count is 0.5 x 109/L or higher.*

Febrile neutropenia

•
Withhold ELREXFIO until absolute neutrophil count is 1 x 109/L or higher and fever resolves.*

Hemoglobin less than 8 g/dL

•
Withhold ELREXFIO until hemoglobin is 8 g/dL or higher.*

Platelet count less than 25,000/mcL

 

Platelet count between 25,000/mcL and 50,000/mcL with bleeding

•
Withhold ELREXFIO until platelet count is 25,000/mcL or higher and no evidence of bleeding.*

Infections and Other Non-hematologic Adverse Reactions†

[see Warnings and Precautions (5.4, 5.6) and Adverse Reactions (6.1)]

Grade 3

•
Withhold ELREXFIO until adverse reaction improves to ≤Grade 1 or baseline.*

Grade 4

•
Consider permanent discontinuation of ELREXFIO.
•
If ELREXFIO is not permanently discontinued, withhold subsequent treatment doses of ELREXFIO (e.g., doses administered after ELREXFIO step-up dosing schedule) until adverse reaction improves to Grade 1 or less.

2.6 Preparation and Administration Instructions

ELREXFIO is intended for subcutaneous use by a healthcare provider only.

ELREXFIO should be administered by a healthcare provider with adequate medical personnel and appropriate medical equipment to manage severe reactions, including CRS and neurologic toxicity, including ICANS [see Warnings and Precautions (5.1, 5.2)].

ELREXFIO 76 mg/1.9 mL (40 mg/mL) vial and 44 mg/1.1 mL (40 mg/mL) vial are supplied as ready-to-use solution that do not need dilution prior to administration.

ELREXFIO is a clear to slightly opalescent, and colorless to pale brown liquid solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer if solution is discolored or contains particulate matter.

Use aseptic technique to prepare and administer ELREXFIO.

Preparation

ELREXFIO vials are for one-time use in a single patient and do not contain any preservatives.

Prepare ELREXFIO following the instructions below (see Table 7) depending on the required dose.

Table 7. Injection Volumes

Total Dose (mg)

Volume of Injection

12 mg

0.3 mL

32 mg

0.8 mL

76 mg

1.9 mL

Remove the appropriate strength ELREXFIO vial from refrigerated storage [2 °C to 8 °C (36 °F to 46 °F)]. Once removed from refrigerated storage, equilibrate ELREXFIO to ambient temperature [15 °C to 30 °C (59 °F to 86 °F)]. Do not warm ELREXFIO in any other way.

Withdraw the required injection volume of ELREXFIO from the vial into an appropriately sized syringe with stainless steel injection needles (30G or wider) and polypropylene or polycarbonate syringe material. Discard unused portion.

Administration

Inject the required volume of ELREXFIO into the subcutaneous tissue of the abdomen (preferred injection site). Alternatively, ELREXFIO may be injected into the subcutaneous tissue at other sites (e.g., thigh).

Do not inject into tattoos or scars or areas where the skin is red, bruised, tender, hard or not intact.

Storage of Prepared Syringe

If the prepared dosing syringe is not used immediately, the syringe may be stored refrigerated between 2 °C to 8 °C (36 °F to 46 °F) for a maximum of 72 hours or between 8 °C to 25 °C (46 °F to 77 °F) for a maximum of 24 hours. Once removed from refrigerated storage, the prepared syringe must be used or discarded.

Medication Guide

MEDICATION GUIDE

   

This Medication Guide has been approved by the U.S. Food and Drug Administration.  Revised: Feb 2026

MEDICATION GUIDE

ELREXFIO® (el-reks-fe-o)

(elranatamab-bcmm)
injection, for subcutaneous use

What is the most important information I should know about ELREXFIO?

ELREXFIO may cause serious side effects, including:

•
Cytokine Release Syndrome (CRS). CRS is common during treatment with ELREXFIO and can also be serious, life-threatening, or can lead to death. Tell your healthcare provider or get medical help right away if you develop any signs or symptoms of CRS, including:
o
fever of 100.4 °F (38 °C) or higher
o
trouble breathing
o
chills
o
dizziness or light-headedness
o
fast heartbeat
o
headache
o
increased liver enzymes in your blood. See “What are the possible side effects of ELREXFIO?” for more information about the signs and symptoms of liver problems.
 
Due to the risk of CRS, you will receive ELREXFIO on a “step-up dosing schedule” and should be hospitalized for 48 hours after the first “step-up” dose and for 24 hours after the second “step-up” dose of ELREXFIO.
o
During the step-up dosing schedule:
▪
for your first dose, you will receive a smaller “step-up” dose of ELREXFIO on Day 1 of your treatment
▪
for your second dose, you will receive a larger “step-up” dose of ELREXFIO, which is usually given on Day 4 of your treatment
▪
for your third dose, you will receive the first full “treatment” dose of ELREXFIO, which is usually given on Day 8 of your treatment
o
If your dose of ELREXFIO is delayed for any reason, you may need to repeat the step-up dosing schedule.
o
Before each step-up dose and the first full treatment dose of ELREXFIO, you will receive medicines to help reduce your risk of CRS. Your healthcare provider will decide if you need to receive medicines to help reduce your risk of CRS with future doses.
o
See “How will I receive ELREXFIO?” for more information about how you will receive ELREXFIO.
•
Neurologic problems. ELREXFIO can cause neurologic problems that can be serious or life-threatening. Tell your healthcare provider or get medical help right away if you develop any signs or symptoms of neurologic problems, including:
o
headache
o
agitation, trouble staying awake, confusion or disorientation, seeing or hearing things that are not real (hallucinations)
o
trouble speaking, thinking, remembering things, paying attention, or understanding things
o
problems walking, muscle weakness, shaking (tremors), loss of balance, or muscle spasms
o
numbness and tingling (feeling like “pins and needles”)
o
burning, throbbing, or stabbing pain
o
changes in your handwriting
•
ELREXFIO is available only through the ELREXFIO Risk Evaluation and Mitigation Strategy (REMS) due to the risk of CRS and neurologic problems. You will receive an ELREXFIO Patient Wallet Card from your healthcare provider. Carry the ELREXFIO Patient Wallet Card with you at all times and show it to all of your healthcare providers. The ELREXFIO Patient Wallet Card lists symptoms of CRS and neurologic problems. Get medical help right away if you develop any of the symptoms listed on the ELREXFIO Patient Wallet Card. You may need to be treated in a hospital.

Your healthcare provider will monitor you for signs and symptoms of CRS and neurologic problems during treatment with ELREXFIO, as well as other side effects, and will treat you if needed. Your healthcare provider may temporarily stop or completely stop your treatment with ELREXFIO if you develop CRS, neurologic problems, or any other side effects that are severe.

If you have any questions about ELREXFIO, ask your healthcare provider.

See “What are possible side effects of ELREXFIO?” for more information about side effects.

What is ELREXFIO?

ELREXFIO is a prescription medicine used to treat adults with multiple myeloma who:

•
have already received at least 4 treatment regimens, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody to treat their multiple myeloma, and
•
their cancer has come back or did not respond to prior treatment.

It is not known if ELREXFIO is safe and effective in children.

Before receiving ELREXFIO, tell your healthcare provider about all of your medical conditions, including if you:

•
have an infection.
•
are pregnant or plan to become pregnant. ELREXFIO may harm your unborn baby.
Females who are able to become pregnant:
o
Your healthcare provider should do a pregnancy test before you start treatment with ELREXFIO.
o
You should use effective birth control (contraception) during treatment and for 4 months after your last dose of ELREXFIO.
o
Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with ELREXFIO.
•
are breastfeeding or plan to breastfeed. It is not known if ELREXFIO passes into your breast milk. Do not breastfeed during treatment and for 4 months after your last dose of ELREXFIO.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive ELREXFIO?

•
ELREXFIO will be given to you by your healthcare provider as an injection under your skin (subcutaneous injection), usually in your stomach-area (abdomen). Your thigh or another area of your body may also be used.
•
See “What is the most important information I should know about ELREXFIO?” for more information about how you will receive ELREXFIO.
•
After you receive your first full “treatment” dose, ELREXFIO is usually given 1 time each week through Week 24.
•
Starting on Week 25, your future doses will usually be given 1 time every 2 weeks.
•
Starting on Week 49, your future doses will usually be given 1 time every 4 weeks.
•
Your healthcare provider will decide the time between doses and how long you will receive treatment with ELREXFIO.

If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment. It is important for you to be monitored closely for side effects during treatment with ELREXFIO.

What should I avoid while receiving ELREXFIO?

Do not drive, operate heavy or potentially dangerous machinery, or do other dangerous activities during treatment with ELREXFIO:

•
for 48 hours after completing each of the 2 doses of ELREXFIO that are part of the “step-up dosing schedule” and your first full treatment dose, and
•
at any time during treatment with ELREXFIO if you develop any new neurologic symptoms such as dizziness, confusion, shaking (tremors), sleepiness, or any other symptom that impairs consciousness, until the symptoms go away.

See “What is the most important information I should know about ELREXFIO?” for more information about signs and symptoms of neurologic problems.

What are the possible side effects of ELREXFIO?

ELREXFIO may cause serious side effects, including:

•
See “What is the most important information I should know about ELREXFIO?”
•
Infections. Upper respiratory tract infections and pneumonia are common during treatment with ELREXFIO. ELREXFIO can cause bacterial and viral infections that are severe, life-threatening, or that may lead to death.
o
Your healthcare provider may prescribe medicines for you to help prevent infections and treat you as needed if you develop an infection during treatment with ELREXFIO.
o
Tell your healthcare provider right away if you develop any signs or symptoms of an infection during treatment with ELREXFIO, including:
▪
fever of 100.4 °F (38 °C) or higher
▪
chills
▪
cough
▪
shortness of breath
▪
chest pain
▪
sore throat
▪
pain during urination
▪
feeling weak or generally unwell
•
Decreased white blood cell counts. Decreased white blood cell counts are common during treatment with ELREXFIO and can also be severe. Fever can happen with low white blood cell counts and may be a sign that you have an infection. Your healthcare provider will treat you as needed.
•
Liver problems. ELREXFIO can cause increased liver enzymes and bilirubin in your blood. These increases can happen with or without you also having CRS. Tell your healthcare provider if you develop any of the following signs or symptoms of liver problems:
o
tiredness
o
loss of appetite
o
pain in your right upper stomach-area (abdomen)
o
dark urine
o
yellowing of your skin or the white part of your eyes

Your healthcare provider will check your blood and monitor you for signs and symptoms of these serious side effects before you start and during treatment with ELREXFIO and may temporarily or completely stop treatment with ELREXFIO if you develop certain side effects.

The most common side effects of ELREXFIO include:

•
tiredness
•
injection site reaction, such as redness, itching, pain, bruising, rash, swelling, tenderness
•
diarrhea
•
muscle and bone pain
•
decreased appetite
•
rash
•
cough
•
nausea
•
fever

The most common severe abnormal blood test results with ELREXFIO include decreased white blood cells, red blood cells, and platelets.


These are not all of the possible side effects of ELREXFIO.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of ELREXFIO.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or healthcare provider for more information about ELREXFIO that is written for health professionals.

What are the ingredients in ELREXFIO?

Active ingredient: elranatamab-bcmm

Inactive ingredients: edetate disodium, histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sucrose, and Water for Injection

Manufactured by: Pfizer Inc., NY, NY 10001

US License No. 2001

Logo

LAB-1551-3.0

For more information on ELREXFIO, go to www.ELREXFIO.com

For more information on Pfizer, go to www.Pfizer.com or call 1-800-438-1985

Additional Resources

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine or vaccine.

Speak with a Pfizer Medical Information Professional regarding your Pfizer medicine or vaccine inquiry.

Available 9AM-5PM ET Monday to Friday; excluding holidays.

 

Submit a medical question for a Pfizer medicine or a vaccine. 

The submission will be reviewed during our standard business hours.

To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this medication, click the link below to submit your information: 
Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website to report an adverse event related to a Pfizer medication, please call (800) 438-1985.

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or by calling (800) 332-1088.